Kornimate/medical-research-clean huggingface dataset:
interim fdg pet/ct in diffuse large b cell lymphoma (dlbcl) patients

Conditions: Lymphoma, Large B-Cell, Diffuse

Summary: newly diagnosed diffuse large b cell lymphoma (dlbcl) patients who enter this study will receive baseline fluorodeoxyglucose (fdg) positron emission tomography (pet) computed tomography (ct) scan at the time of initial staging. the patients will be diagnosed and undergo initial staging according to the catholic university lymphoma group (culg) protocol. after 1 cycle of rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisone (r-chop) chemotherapy, early interim fdg pet/ct will be obtained after the patient recovers from nadir (usually 13 to 16 days after) following the administration of first cycle of r-chop,immediately before the second cycle of r-chop. the result of early interim fdg pet/ct study will not impact patient management, except in rare case where newly developed lesion is found and biopsy confirmed. the same pet/ct system and analysis software will be used for all scans from baseline to surveillance for all patients enrolled in this study. after 3 cycles of r-chop, a mid-therapy interim fdg pet/ct will be obtained. patients with newly developed lesion will receive different chemotherapy regimen, while patients with stable disease, partial metabolic response or complete metabolic response will continue to receive 3 more cycles of r-chop. after the completion of 6 cycles of r-chop, the patients will receive a fdg pet/ct scan for response assessment. selected patients with persistent disease or very bulky tumor volume on initial staging images will receive additional radiation therapy. the patients will be followed up every 3 months for 2 years from beginning of therapy. physical examination and lab studies will be done usually every 3 months. imaging studies will be performed every 3 months alternating between enhanced ct and fdg pet/ct and noted when different schedule is applied for surveillance. the end points are changes in fdg uptake measurements between the baseline and early interim fdg pet/ct, and between baseline and mid-therapy interim fdg pet/ct scans; response assessment following completion of 6 cycles of r-chop with or without radiation therapy assessed by international workshop criteria (iwc)+pet and pet response criteria in solid tumors (percist) guideline; and the 2 year disease free survival.


Eligibility criteria:
inclusion criteria: * cd20+ diffuse large b cell lymphoma confirmed * therapy naïve for lymphoma * 19 years or older * written informed consent exclusion criteria: * cannot understand informed consent * age under 19 years old * previous chemotherapy or radiation therapy for lymphoma * known pregnancy or urine/serum hcg (+) * unable to lie down still on back for about 30 minutes

Keywords: diffuse, large b-cell, lymphoma 18f fluorodeoxyglucose radionuclide-emission computed tomography
opera® for aromatase inhibitor-related arthralgia management (aia)

Conditions: Breast Cancer; Hormone Receptor Positive Tumor; Arthralgia

Summary: in this phase ii, multicenter, self-controlled clinical trial, we will evaluate the safety and efficacy of opera® for treating anti-aromate inhibitors (ais) induced arthralgia. the diagnosis of arthralgia will be based on the nci-ctcae v4.0 grade of ≥ 1 , a disorder characterized by a sensation of marked discomfort in a joint, mild pain (grade 1). arthralgia will be assessed at the enrollment and every two months until the sixth month.

aromatase inhibitors (ais) are recommended for the adjuvant treatment of hormone receptor positive breast cancers in the post-menopausal population. compared with tamoxifen, third generation aromatase inhibitors have been shown to significantly improve disease free survival (dfs), and include the steroidal inhibitor exemestane, and the nonsteroidal inhibitors, anastrozole and letrozole. although the ais are associated with fewer thromboembolic events and endometrial abnormalities than is tamoxifen, approximately 25% of postmenopausal women on ai report arthralgia, skeletal, and muscle pain. the multicentre double-blind placebo-controlled ma.17 trial by the national cancer institute of canada clinical trials group revealed marked increases in arthralgia (25% vs. 21%) and myalgia (15% vs. 12%) in patients on letrozole as compared with those on placebo. the intergroup exemestane study shown a link between arthralgia and the ai exemestane (5.4% exemestane vs. 3.6% tamoxifen).the arimidex, tamoxifen alone or in combination (atac) trial, after 68 months' median follow-up, showed that the incidence of arthralgia was significantly higher in the anastrozole group than in the tamoxifen group \[1100 of 3092 (35.6%) vs. 911 of 3094 (29.4%) patients\]. currently, evidences of drugs efficacy to reduce these side effects are sparse.opera® (gamfarma srl, milan, italy) is a new dietary supplement where α-lipoic acid (240mg), bs (40mg), msm (200mg) and bromelain (20mg) are combined together in a single hard-gelatin capsule. the aim of this prospective study is to determine the efficacy and safety of opera® supplementation in a series of patients affected by arthralgia during ai treatment.

Eligibility criteria:
inclusion criteria: * 18 years or older * karnofsky performance score≥70 * indication for ai treatment in adjuvant setting for breast cancer * arthralgia with grade ≥0-1 exclusion criteria: * concomitant diseases, e.g. diabetes, renal insufficiency, alcohol abuse * concomitant rheumatological disease (rheumatoid arthritis, spondyloarthropathies, psoriatic arthritis, etc.) * concomitant endocrinological disease (acromegaly , emocromatosis, etc) * any conditions that would complicate arthralgia assessment (e.g. trauma, glucocorticoid withdrawal, hypertrophic osteoarthropathy, osteoarthritis, avascular necrosis, gout, systemic lupus erythematosus, septic arthritis, etc.)

Keywords: breast cancer luminal tumor anti-aromatase inhibitors arthralgia dietary supplement
clinical subgroups in patellofemoral pain syndrome

Conditions: Patellofemoral Pain Syndrome

Summary: patellofemoral pain syndrome (pfps) is a multifactorial pathology characterized by diffuse retropatellar and peripatellar pain in the knee joint, exacerbated by overloading activities on the patellofemoral joint. however, this disease showed high degree of patients not responsive to therapeutic strategies. this condition occurred because several factors is related to disease such as: (1) proximal factors (involving trunk and hip), (2) local factors (surrounding and or within the patellofemoral joint) and (3) distal factors (involving ankle and foot). thus, the identification of clinical subgroups based in anatomic changes (proximal, local and distal factors) is a recent strategy that could help in the therapeutic strategies focused on the etiology of the disease, improve responsiveness to treatment, clinical and functional benefits.


Eligibility criteria:
inclusion criteria: * peripatellar or retropatellar pain in at least two of the following situations: squatting, running, kneeling, jumping, climbing or descending stairs and sitting for a prolonged period of time for at least three months. exclusion criteria: * engaged in systematic exercise with focus on lower limb in the last six months and had an injury to the hip and ankle joint in the last 12 months.
obstructive sleep apnea & covid-19 outcomes

Conditions: COVID; Obstructive Sleep Apnea; Pneumonia

Summary: covid-19 infection is an on-going pandemic with worse diagnosis in adults with comorbid conditions such as hypertension and cardiopulmonary diseases. obstructive sleep apnea (osa) is common in those comorbidities and may contribute to worse prognosis for the covid-19 cases.

the investigators' primary aim is to address the association between the high probability of having osa and covid-19 outcomes within 28 days of the hospitalization. secondary outcomes will be conducting a polysomnography in cases with high probability of having osa compared to those with low probability, approx. 4 months after the covid-19 diagnosis, and re-evaluate the association of the verified osa diagnosis and severity with the outcomes in the first 4 weeks as well as with the outcomes after 4 months.

Eligibility criteria:
inclusion criteria: * adult patients with covid 19 diagnosis * ability to read and speak * signed informed consent. exclusion criteria: * subjects with limited life expectancy due to advanced renal disease or uncontrolled malignancies * subjects with alcohol dependency

Keywords: covid obstructive sleep apnea pneumonia
implications of different analgesic models on inflammatory markers after laparoscopic cholecystectomy

Conditions: Perioperative Pain

Summary: postoperative abdominal and shoulder pain that are experienced in patients undergoing laparoscopic cholecystectomy (lc) is significant. although it is generally less sever than post open cholecystectomy pain, it still causes an avoidable distress in the first 24 hours postoperatively

the incidence of pain after laparoscopy may be as high as 36 to 63 percent and is attributed to the carbon dioxide gas (co2) used to induce pneumo-peritoneum1. the residual part of co2 remains in the peritoneal cavity for several days after the operation and causes stretching of the phrenic nerve endings, local hypothermia, and diaphragmatic irritation by carbonic acid formation

Eligibility criteria:
inclusion criteria: * patients scheduled for laparoscopic cholecystectomy. * age spectrum of 18 - 55 years * asa i, ii * have no comorbid chronic medical diseases exclusion criteria: * patients with co morbid medical diseases * age outside the specified range * acute inflammation of the gall bladder * critically ill patient * emergency operations * patient refusal
effects of preoperative warming of patients on postoperative hypothermia and shivering

Conditions: Hypothermia

Summary: the investigators want to evaluate the effect of prewarming on the rate of postoperative hypothermia and shivering and to compare sublingual versus tympanic temperature assessment during the perioperative period in patients. patients will be randomly assigned to 4 groups with different duration of prewarming. body temperature will be recorded regularly by sublingual and tympanic (by thermocouple) measurement. incidence of hypothermia (temp. \< 36°c) and shivering will be assessed postoperatively.

inadvertent perioperative hypothermia causes many serious complications. therefore, prevention from, detection and therapy of hypothermia is essential. the appropriate methods of temperature assessment are still under debate as well as the effect and necessary duration of active prewarming of patients to avoid postoperative hypothermia and shivering. the aim of our study is to evaluate the effect of prewarming on the rate of postoperative hypothermia and shivering and to compare sublingual versus tympanic temperature assessment during the perioperative period in patients undergoing elective minor surgery. the investigators plan to include patients scheduled for routine minor surgery of approximately 1h duration. patients will be randomly assigned to 4 groups with different duration of active prewarming. body temperature will be recorded regularly by sublingual and tympanic (by thermocouple) measurement. incidence of hypothermia (temp. \< 36°c) and shivering will be assessed postoperatively.

Eligibility criteria:
inclusion criteria: * patients scheduled for minor surgery (planned duration approximately \<1h). * age 18-75yrs, * asa i-ii physical status exclusion criteria: * emergency surgery, * pregnant patients, * patients not able to give informed consent, * duration of surgery \>2h, * necessary postoperative mechanical ventilation

Keywords: hypothermia, accidental prewarming body temperature monitoring preoperative warming sublingual temperature assessment tympanic temperature assessment
multifidus cervicis plane block vs. sham block for posterior cervical spine fusion surgery

Conditions: Cervical Spine Fusion

Summary: the goal of this randomized, double-blinded, clinical trial is to assess the benefit of administering a multifidus cervicis plane (mcp) block compared to a sham block as a method of postoperative pain control in patients undergoing posterior cervical spine fusion surgery. the main question it aims to answer is if the mcp block group will have reduced maximum pain scores during the first 24 postoperative hours compared to the sham block group. participants will receive preoperative bilateral mcp blocks on the back of their neck using the standard of care local anesthetic solution that consists of 30 mls 0.25% bupivacaine + 0.5 ml (5 mg) preservative-free dexamethasone + 0.1 ml epinephrine (mcp block group). researchers will compare the mcp block to the preoperative sham block which consists of injecting 3 ml of normal saline into the same area (sham block group) to compare the postoperative pain scores between the groups as a main objective. the secondary objectives are: * postoperative opioid consumption during hospitalization and at 2 weeks after discharge. * the amount and type of non-opioid analgesics used during hospitalization. * the occurrence of postoperative nausea and vomiting (ponv) and the use of antiemetics. * hospital and post anesthesia care unit length of stay (los). * monitor the safety of the study interventions during hospitalization and readmissions within 30 days of discharge. * patient satisfaction with pain management and overall satisfaction with the surgery experience.


Eligibility criteria:
inclusion criteria: 1. patients 40-80 years old, males and females, of any race and any ethnic group. 2. patients are scheduled for elective primary posterior cervical spine fusion surgery (csfs) to be performed by one of the spine surgeons in the study. 3. ability to speak and read english 4. patients with american society of anesthesiology (asa) physical status score i- iv exclusion criteria: 1. emergency posterior csfs. 2. revision surgery or history of previous cervical spine surgery 3. history of allergy to local anesthetics or steroids. 4. patients who are coagulopathic at the time of surgery 5. patients with contraindications to mcp blocks, including but not limited to anatomical abnormality or previous surgical intervention that limits or prevents receiving the blocks 6. infection at the site of the block. 7. weight \< 40 kg to avoid local anesthetic toxicity. 8. patients on chronic or continuous opioid use of \> 50 mme (morphine milli-equivalent) per day for at least 30 days within 90 days prior to surgery. 9. patients with a history of chronic inflammatory conditions such as multiple sclerosis 10. refusal to participate or lack of providing the study consent

Keywords: posterior cervical spine fusion surgery multifidus cervicis plane block
a study evaluating tocilizumab in pediatric patients hospitalized with covid-19

Conditions: COVID-19

Summary: this is a single-arm, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and exploratory efficacy of tocilizumab (tcz) for the treatment of pediatric patients from birth to less than 18 years old hospitalized with covid-19 and who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.


Eligibility criteria:
inclusion criteria: * hospitalized with covid-19 confirmed per a positive pcr of any specimen (e.g., respiratory, blood, urine, stool, or other bodily fluid) and evidenced by chest x-ray or ct scan * receiving systemic corticosteroids at baseline * oxygen saturation \ 92% at screening and baseline exclusion criteria: * gestational age \< 37 weeks * known severe allergic reactions to tcz or other monoclonal antibodies * active tuberculosis infection * uncontrolled active bacterial, fungal, viral, or other infection (besides covid-19) * diagnosis or suspected diagnosis of multisystem inflammatory syndrome in children (mis-c) * in the opinion of the investigator, progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments * have received oral anti-rejection or immunomodulatory drugs (including tcz) within the past 3 months prior to enrollment * treatment with an investigational drug within 5 drug-elimination half-lives or 30 days, whichever is longer, of enrollment (except for anti-sars-cov-2 antibodies or directly-acting antivirals) * participating in another interventional drug clinical trial (except for anti-sars-cov-2 antibodies or directly-acting antivirals)
pentoxifylline administration in hemodialysis patients

Conditions: Anemia Renal

Summary: the aim of the study is to assess the impact of pentoxifylline administration on the modulation of hyporesponsiveness to erythropoietin stimulating agents in hemodialysis patients

this is a prospective, randomized, controlled study to assess the impact of pentoxifylline administration on the modulation of hyporesponsiveness to erythropoietin stimulating agents in hemodialysis patients by determining several outcomes from the intervention and control groups at the end of the study.these outcomes include;the difference in hemoglobin and hematocrit concentration , the difference in inflammatory markers tumor necrosis factor alpha (tnf-α), interleukin-1 beta (il-1β),the difference in the dosage of erythropoiesis stimulating agents ,and the erythropoietin stimulating agents (esa) resistance index (eri).

Eligibility criteria:
inclusion criteria: * adults (18 years or over). * stable hemodialysis \>6 months. * regular haemodialysis (3 times/ week). * esa resistant anemia (hb \<10 mg/dl for 6 mo.). * esa dose of \>8000 iu/wk. exclusion criteria: * inadequate hemodialysis. * hyperparathyroidism (pth\>800 pg/l). * known hypersensitivity to, or intolerance of pentoxifylline. * absolute or functional iron deficiency (ferritin \< 100 μg/l and/or transferrin saturation \< 20%). * presence of systemic haematological disease (including antibody-mediated pure red cell aplasia) or known haemoglobinopathy. * major surgery, infection, inflammatory diseases, acute myocardial infarction or malignancy within the last 3 months. * patients with chronic liver disease and patients who had received immunosuppressive therapy.

Keywords: pentoxifylline
intervention for (those) recently informed of seropositive status (iriss)

Conditions: HIV Infections

Summary: an intervention designed to increase positive affect in a population newly diagnosed with hiv will be effective at improving affect and hiv-related outcomes such as mental and physical health, coping and coping resources.

the study is a randomized controlled trial of a 5-session positive affect skills intervention compared to an attention-matched control condition. participants will be 200 men and women who have tested positive for hiv within the past 12 weeks. both intervention and control sessions will be approximately one hour long and will be administered one-on-one by trained facilitators. both groups will have daily home practice over the 5 weeks of the intervention. at the end of the assessment period, participants in the control condition will have the opportunity to attend a ½ day group session that provides a condensed version of the positive affect skills taught in the intervention condition. participants will complete assessments at four points and cd4 and viral load assays will be run at 3 time points.

Eligibility criteria:
inclusion criteria: * have been informed they were hiv positive within the past 12 weeks * speak english or spanish * be 18 years or older * have the ability to provide informed consent to be a research participant. exclusion criteria: * inability to provide informed consent, as evidenced by cognitive impairment as assessed by trained interviewers and confirmed by a licensed clinical psychologist * active psychosis as assessed by trained interviewers and confirmed by clinical psychologist

Keywords: hiv mood emotion coping aids affect adults diagnosed
cocaine opioid oxytocin option - limited

Conditions: Opioid Use Disorder; Cocaine Use Disorder

Summary: this is a pilot feasibility study assessing the tolerability of chronic administration of intranasal oxytocin to patients receiving methadone at an opioid replacement clinic who are actively using cocaine.


Eligibility criteria:
inclusion criteria: * enrolled as a patient in the san francisco general hospital opioid treatment outpatient program * stable dose of methadone for at least the past two weeks * at least one routine urine toxicology screen positive for cocaine in the past month exclusion criteria: * positive urine pregnancy test * use of illicit drugs in the past month (with the exception of cocaine or cannabis) * currently meets diagnostic and statistical manual-5 (dsm-v) criteria for severe major depressive disorder with suicidal thoughts or actions * history of psychotic or moderate-severe alcohol use disorder as defined by dsm-v criteria * severe neuropsychological disorder, brain trauma, epilepsy * sensitivity to preservatives (in particular e 216, e 218 and chlorobutanol hemihydrate) * nasal obstruction, discharge, or bleeding * habitually drinks large volumes of water * taking testosterone, estrogen/progesterone supplement, or serotonin-1a receptor agonists/antagonists

Keywords: addiction oxytocin tolerability
the effects of mydriatic eye drops in retinopathy of prematurity examinations

Conditions: Retinopathy of Prematurity; Mydriasis; Neonatal Disease; Analgesic Adverse Reaction

Summary: retinopathy of prematurity (rop) is a retinal disorder of preterm neonates and a potential cause of blindness. as early diagnosis and treatment preserve vision, very low birth weight infants must be screened for rop. mydriatic eye drop administration is essential to perform funduscopic evaluations. the most commonly used mydriatic drops for pupil dilatation are 0.5-1.0% tropicamide and/or 0.5-1.0% phenylephrine or 0.2-1.0% cyclopentolate. phenylephrine, an alpha-1 sympathomimetic agonist, is readily absorbed from conjunctival mucosa and has a potent systemic vasopressor effect. tropicamide causes cycloplegia by inhibition of ciliary muscle contraction and has a short acting para-sympatholytic effect. systemic absorption of mydriatic eye drops has been associated with cardiovascular, respiratory and gastrointestinal adverse effects. systemic side effects include apnea, desaturation, increased heart rate and blood pressure, delayed gastric emptying, and feeding intolerance. the data about the effects of mydriatics on cerebral blood flow and tissue oxygenation are sparse. cerebral blood flow autoregulation depends in part on the adrenergic and cholinergic control of cerebral vasculature, but whether mydriatics have an effect on cerebral haemodynamics is unknown. near-infrared spectroscopy and doppler ultrasonography (us) are non-invasive methods commonly used for neuromonitorization in nicus. the regional blood flow changes measured using doppler us have been reported to be associated with cerebral oxygenation and indicate a high correlation with nirs in newborns. the aim of this study was to evaluate the effects of mydriatic eye drops on cerebral oxygenation and blood flow in preterm infants by nirs and doppler us.


Eligibility criteria:
inclusion criteria: * babies born at gestational age less than 34 weeks and/or birth weight below 2000 grams. infants undergoing their first retinopathy examination. exclusion criteria: * congenital anomaly * continued mechanical ventilation support * having pain from a different cause and/or requiring concurrent analgesic use * sedation analgesia administered within the last 24 hours * hemodynamically unstable * intraventricular hemorrhage, neurological dysfunction * receiving anticonvulsant therapy.

Keywords: cerebral blood flow cerebral oxygenation mydriatic eye drops doppler ultrasonography retinopathy of prematurity nirs neonate